Article: an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.
Distributor: any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties.
Downstream user (DU): any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a mixture in the course of his industrial or professional activities. A distributor or a consumer is not a downstream user. A re-importer exempted pursuant to Article 2(7)(c) shall be regarded as a downstream user.
Exposure Scenario: the set of conditions, including operational conditions and risk management measures, that describes how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment. These exposure scenarios may cover one specific process or use or several processes or uses as appropriate.
Full study report: a complete and comprehensive description of the activity performed to generate the information. This covers the complete scientific paper as published in the literature describing the study performed or the full report prepared by the test house describing the study performed.
Identified use: a use of a substance on its own or in a preparation, or a use of a preparation, that is intended by an actor in the supply chain, including his own use, or that is made known to him in writing by an immediate downstream user.
Importer: any natural or legal person established within the Community who is responsible for import.
IUCLID: a database and management system for the administration of data on chemical substances.
Mixture: a mixture or solution composed of two or more substances.
Monomer: a substance capable of forming covalent bonds with a sequence of additional like or unlike molecules under the conditions of the relevant polymer-forming reaction used for the particular process.
Non-isolated intermediate: an intermediate that during synthesis is not intentionally removed (except for sampling) from the equipment in which the synthesis takes place.
Notified substance: a so-called ELINCS substance, for which a notification has been submitted and which could be placed on the market in accordance with Directive 67/548/CEE. These substances have a "notification number."
Only Representative (OR): A natural or legal person in the Community appointed to fulfill the obligations of an importer outside the Community who manufactures a substance on its own, in mixtures, or in articles, formulates a mixture or produces an article that is imported into the Community.
Phase-in substance: a substance that meets at least one of the following criteria:
1. It is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS).
2. It was manufactured in the Community, or in the countries acceding to the European Union on January 1, 1995 or on May 1, 2004, but not placed on the market by the manufacturer or importer, at least once in the 15 years before the entry into force of this Regulation, provided the manufacturer or importer has documentary evidence of this.
3. It was placed on the market in the Community, or in the countries acceding to the European Union on January 1, 1995 or on May 1, 2004, before entry into force of this Regulation by the manufacturer or importer and was considered as having been notified in accordance with the first indent of Article 8(1) of Directive 67/548/CEE, but does not meet the definition of a polymer as set out in REACH, provided the manufacturer or importer has documentary evidence of this.
Polymer: a substance consisting of molecules characterized by the sequence of one or more types of monomer units (reacted form of a monomer substance in a polymer) and distributed over a range of molecular weights.
Preparation: a mixture or solution composed of two or more substances. A paint or resin made up of several substances is a preparation. Composite materials, alloys, lubricants, paints, varnishes, adhesives, etc. are preparations.
Producer of an article: any natural or legal person established within the Community who makes or assembles an article within the Community.
REACH-IT: the online IT system of ECHA.
Registrant: the EU manufacturer or the importer of a substance or the EU producer or importer of an article submitting a registration for a substance.
Registrant's own use: an industrial or professional use by the registrant.
Robust study summary: a detailed summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an independent assessment of the study minimising the need to consult the full study report.
Study summary: a summary of the objectives, methods, results and conclusions of a full study report providing sufficient information to make an assessment of the relevance of the study.
Substance: a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
Substance Information Exchange Forum (SIEF): is a forum, formed after the pre-registration phase, to share data on a given phase-in substance.
Substance of Very High Concern (SVHC): Substances that are either
1. CMRs category 1 or 2;
2. PBTs and vPvBs meeting the criteria of Annex XIII; or
3. other such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points 1 and 2 and which are identified on a case-by-case basis.
Supplier of a substance or a preparation: any EU manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation.
Use: means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilization.
